AIMSCREEN BZO

GUDID 00695684423254

Lateral flow immunoassay for the detection of Benzodiazepines (BZO) in urine

GERMAINE LABORATORIES, INC

Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapid Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapid Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical

• Primary Device ID: 00695684423254
• NIH Device Record Key: eb67e332-df77-46da-84b8-77daf284e3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIMSCREEN BZO
• Version Model Number: 42325
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684423251 [Unit of Use]
GS1	00695684423254 [Primary]

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazipine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-04

Devices Manufactured by GERMAINE LABORATORIES, INC

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• 00695684410117 - SAFECUP III MULTIDRUG 11: 2022-08-25 Rapid qualitative tests for the detection of drugs of abuse in urine. All-in-One Cup, tests for AMP, BAR, BZO, BUP, COC, MTD, MD
• 00695684444310 - SAFECUP III 13 PANEL: 2022-08-25
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• 06956847540756 - Mosie Baby Ovulation Test: 2019-10-29 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel